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Health Highlights: Nov. 13, 2018
Posted today in Medical
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: In-Home Services Coming for Seniors With Private Medicare Advantage Plans In-home services such as help with household chores and caregiver respite will be available to seniors with private Medicare Advantage plans in more than 20 states next year. A health-related reason is needed to qualify, and costs will... Read more
AHA: Physical Activity Guidelines for Americans Updated
Posted today in News for Health Professionals
TUESDAY, Nov. 13, 2018 -- Key guidelines for recommended physical activity in Americans have been updated, according to a special report published online Nov. 12 in the Journal of the American Medical Association to coincide with the annual meeting of the American Heart Association, held from Nov. 10 to 12 in Chicago. Katrina L. Piercy, Ph.D., R.D., from the U.S. Department for Health and Human Services in... Read more
AHA: Limited Benefit for n-3 Fatty Acids in CVD, Cancer Prevention
Posted today in News for Health Professionals
TUESDAY, Nov. 13, 2018 -- Omega-3 fatty acids and vitamin D do not significantly reduce major cardiovascular events or cancer incidence, according to two studies published online Nov. 10 in the New England Journal of Medicine to coincide with the annual meeting of the American Heart Association, held from Nov. 10 to 12 in Chicago. JoAnn E. Manson, M.D., Dr.P.H., from Brigham and Women's Hospital in Boston, and... Read more
AHA: PTSD Common Among Those Who Suffer Tear in the Aorta's Wall
Posted today in Medical
TUESDAY, Nov. 13, 2018 (American Heart Association) -- The sharp and sudden pain from an aortic dissection, along with the emergency treatment that follows, can lead to post-traumatic stress disorder years later, a new study finds. An aortic dissection is a life-threatening condition in which a tear in the wall of the aorta -- the major artery carrying blood out of the heart -- allows blood to rush between the... Read more
18F-FDG PET Algorithm Allows Early Prediction of Alzheimer's
Posted today in News for Health Professionals
TUESDAY, Nov. 13, 2018 -- Fluorine 18 (18F) fluorodeoxyglucose (FDG) positron emission tomography (PET) of the brain can be used to develop a deep learning algorithm for early prediction of Alzheimer's disease (AD) that has high specificity and sensitivity, according to a study published online Nov. 6 in Radiology. Yiming Ding, from the University of California in San Francisco, and colleagues collected prospective... Read more
Denosumab Promising for TDT-Induced Osteoporosis Treatment
Posted today in News for Health Professionals
TUESDAY, Nov. 13, 2018 -- Denosumab (DNM), a fully human monoclonal antibody against the receptor activator of nuclear factor kappa-B ligand (RANKL), may be beneficial for managing transfusion-dependent thalassemia (TDT)-induced osteoporosis, according to a study published online Oct. 31 in Blood Advances. Ersi Voskaridou, M.D., from "Laiko" General Hospital in Athens, Greece, and colleagues randomly assigned... Read more
No Efficacy Signal for Fluoxetine in EV-D68 Acute Flaccid Myelitis
Posted today in News for Health Professionals
TUESDAY, Nov. 13, 2018 -- The antiviral agent fluoxetine is well tolerated but is not effective for patients with proven or presumptive enterovirus D68-associated acute flaccid myelitis (AFM), according to a study published online Nov. 9 in Neurology. Kevin Messacar, M.D., from the University of Colorado School of Medicine in Aurora, and colleagues compared serious adverse events (SAEs), adverse effects, and... Read more
Murder of Family, Friends Takes Highest Toll on Black Teens
Posted today in Medical
TUESDAY, Nov. 13, 2018 -- Teens who lose a family member or friend to murder have an increased risk of suicide, and black teens are most likely to face this kind of heartbreak, a new study finds. University of Pittsburgh researchers analyzed the results of a 2014 survey of just over 1,600 teens, aged 14 to 19, in Allegheny County and found that 13 percent said a friend or family member had been murdered. However,... Read more
Exercise Makes Even the 'Still Overweight' Healthier: Study
Posted today in Medical
TUESDAY, Nov. 13, 2018 -- Heavyset folks who exercise regularly shouldn't get discouraged if they can't seem to shed more weight, no matter how hard they try. A new study suggests that their regular workouts are still contributing to better overall heart health, making them "fat but fit" and helping them live longer. People who are obese-but-fit have lower resting pulse rates, less body fat, higher lean muscle mass... Read more
Heart Failure Patients Shouldn't Stop Meds Even if Condition Improves: Study
Posted today in Medical
TUESDAY, Nov. 13, 2018 -- There's bad news for heart failure patients with dilated cardiomyopathy who'd like to stop taking their meds. Any progress they've seen on medication is likely to fade once they stop taking their heart drugs, new clinical trial results show. About 40 percent of a small group of patients wound up back on their medications after their heart function faltered, said lead researcher Brian... Read more
FDA Approves Yupelri (revefenacin) for Chronic Obstructive Pulmonary Disease (COPD)
Posted 4 days ago in New Drug Approvals
DUBLIN, Ireland, HERTFORDSHIRE, England and PITTSBURGH, Nov. 9, 2018 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") and Mylan N.V. (NASDAQ: MYL) ("Mylan") today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Yupelri (revefenacin) inhalation solution for the maintenance treatment of patients with... Read more
FDA Approves Newly Formulated OTC Primatene Mist (epinephrine) to Treat Mild Asthma
Posted 5 days ago in New Drug Approvals
RANCHO CUCAMONGA, Calif., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) announced today that the U.S. Food and Drug Administration (FDA) granted approval of its New Drug Application (NDA) for Primatene Mist (epinephrine inhalation aerosol bronchodilator suspension), which is delivered by a metered dose inhaler (MDI) with a non-chlorofluorocarbon (CFC) propellant. Primatene Mist is... Read more
FDA Approves Empliciti (elotuzumab) Plus Pomalidomide and Dexamethasone, a New Immunotherapy Combination for Certain Patients with Relapsed or Refractory Multiple Myeloma
Posted 7 days ago in New Drug Approvals
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.1 In... Read more
FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta
Posted 10 days ago in New Drug Approvals
REDWOOD CITY, Calif., Nov. 02, 2018 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (NASDAQ: CHRS), today announced that the U.S. Food and Drug Administration (FDA) has approved Udenyca (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients with cancer receiving myelosuppressive chemotherapy. Udenyca is Coherus’ first drug to receive FDA or EC a... Read more
FDA Approves Lorbrena (lorlatinib) for Previously-Treated ALK-Positive Metastatic Non-Small Cell Lung Cancer
Posted 10 days ago in New Drug Approvals
November 2, 2018 Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved Lorbrena [lor-BREN-ah] (lorlatinib), a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic... Read more
Trevena Receives Complete Response Letter for Oliceridine from FDA
Posted 11 days ago in New Drug Applications
November 2, 2018 -- Trevena, Inc. (NASDAQ: TRVN) today announced the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for oliceridine. “While we are disappointed with FDA’s decision, we continue to believe in the strength of the data and the ultimate approvability of oliceridine,” said Carrie L. Bourdow,... Read more
Sage Therapeutics Announces FDA Advisory Committee Votes 17-1 in Support of Benefit-Risk Profile of Zulresso (brexanolone) Injection for Treatment of Postpartum Depression
Posted 11 days ago in New Drug Applications
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 2, 2018-- Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) jointly voted (17 yes,... Read more
Alkermes Reports on Outcome of FDA Advisory Committee Meeting on ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder
Posted 12 days ago in New Drug Applications
DUBLIN, Nov. 1, 2018 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA), met to review the company's New Drug Application (NDA) for ALKS 5461. The committee jointly voted that the benefit-risk profile was not adequate to support... Read more
Heron Announces FDA Submission of HTX-011 NDA for Postoperative Pain Management
Posted 13 days ago in New Drug Applications
SAN DIEGO, Oct. 31, 2018 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011. HTX-011 is an investigational,... Read more
FDA Grants Priority Review for Sanofi's Dengue Vaccine Candidate
Posted 2 weeks ago in New Drug Applications
BRIDGEWATER, N.J., Oct. 30, 2018 /PRNewswire/ -- The United States Food and Drug Administration (FDA) has accepted a Biologics License Application for Sanofi Pasteur's dengue vaccine. The dengue vaccine candidate has been granted priority review by the FDA as it would represent the first and only medical prevention tool against dengue, including severe dengue, which is considered an unmet medical need. The FDA... Read more
Entasis Therapeutics Announces Zoliflodacin Phase 2 Results Published in The New England Journal of Medicine
Posted 5 days ago in Clinical Trials
WALTHAM, Mass., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Entasis Therapeutics (NASDAQ: ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, announced that The New England journal of Medicine (NEJM) published results from a Phase 2 clinical trial evaluating the safety and efficacy of zoliflodacin in patients with uncomplicated gonorrhea. Zoliflodacin... Read more
Janssen Reports Positive Topline Results for FLAIR Phase 3 Study of a Novel, Long Acting Injectable Two-Drug Regimen for the treatment of HIV-1
Posted 12 days ago in Clinical Trials
CORK, IRELAND, October 31, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson today confirmed positive topline results from the global, Phase 3 FLAIR (First Long-Acting Injectable Regimen) study of a long-acting, injectable two-drug regimen (2DR) for the treatment of HIV. The study, conducted by ViiV Healthcare, showed long-acting rilpivirine and cabotegravir, injected once a month, had... Read more
Two-year data for Novartis brolucizumab reaffirm superiority versus aflibercept in reducing retinal fluid in patients with nAMD
Posted 2 weeks ago in Clinical Trials
Basel, 27 October, 2018 - Novartis announced additional brolucizumab Phase III results from year two that reaffirmed its positive year one findings. Brolucizumab met its primary endpoint of non-inferiority versus aflibercept in best corrected visual acuity (BCVA) and exhibited superiority in key retinal outcomes at year one (48 weeks)[1],[2]. Secondary endpoints at year two (96 weeks) reaffirmed superiority of... Read more
New STAIRWAY Study Data Shows Potential for Extended Durability With Faricimab in Wet Age-Related Macular Degeneration (AMD)
Posted 2 weeks ago in Clinical Trials
South San Francisco, CA -- October 27, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase II STAIRWAY study which explored the extended durability of faricimab (RG7716) in the treatment of wet age-related macular degeneration (AMD), a leading cause of blindness in people aged 60 and over in the United States.3 At 52 weeks, faricimab patients... Read more
Biogen and Eisai Announce Presentation of Detailed Analyses from the Phase 1b Long-Term Extension Study of Aducanumab at Clinical Trials on Alzheimer’s Disease (CTAD)
Posted 2 weeks ago in Clinical Trials
CAMBRIDGE, Mass., Oct. 26, 2018 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced that Biogen presented results at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting, in Barcelona, Spain, from the recent 36- and 48-month analyses of the ongoing long-term extension (LTE) of the Phase 1b study of aducanumab, an... Read more
